Arthrex® AR-9217CRecalls & reported problems

Arthrex, Inc. · Instrument Case, Univers VaultLock Glen · Class 1

Adverse event reports: 3
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867249752), received between May 1, 2024 and Jun 14, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Corroded” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Corroded2
Pitted1

Patient problems

Insufficient Information2
No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

MalfunctionJun 14, 2024Pitted; Pitted
IT WAS REPORTED THAT THE FOLLOWING SETS ARE CHIPPED AND NEED TO BE REPLACED; AR-9217C, AR-9400C4, AR-9225C, AR-9226ABC, AR-9226UBC, AR-9226CC, AR-9501-HC2, AR-9501-HC1, AR-9615C-1, AR-9615C-2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19536337 ↗
MalfunctionMay 21, 2024Corroded; Corroded
IT WAS REPORTED THAT THE CASE CADDIES HAVE RUST ON THE BOTTOM.
Patient problems: Insufficient Information
MAUDE report 19357646 ↗
MalfunctionMay 1, 2024Corroded; Corroded
IT WAS REPORTED BY THE AGENCY THAT THE FOLLOWING DEVICES ARE CORRODED: AR-9231-01PP QTY 1 AR-9231-02PP QTY 1 AR-9231-03PP QTY 1 AR-9231-04PP QTY 1 AR-9217CPP QTY 2 AR-9225CK QTY 1 AR-9225CP QTY 1
Patient problems: Insufficient Information
MAUDE report 19222610 ↗

Device details

UDI-DI	`00888867249752`
Brand	Arthrex®
Model	AR-9217C
Company	Arthrex, Inc.
Product code	MDM · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Apr 4, 2023

Device type (GMDN): Device sterilization/disinfection container, reusable

A receptacle designed to hold wrapped and/or unwrapped medical/dental devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s). It may be designed as a tray to allow full or partial immersion of the devices in a liquid disinfectant, or as an enclosed box to prevent contamination once the sterilization process is finished. The container may also be used for transport and storage of the processed devices, and may have features such as an expiry date label, breathing filter, built-in slots or inserts to hold instruments, and stacking capabilities. This is a reusable device.

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.